Job Description

We are looking for enthusiasts KVALITO Consulting Group is a strategic partner and global Life Science network for regulated industries with a focus on quality. Headquartered in Basel, Switzerland, we have subsidiaries in Germany, Czech Republic, Ireland and Malaysia. With our enthusiasm for progressive technologies and our in-depth knowledge of industry best practices and regulations, we drive effective and efficient project delivery to keep our industry-leading clients ahead of the competition. Our leadership and consultants combine decades of experience in enterprise environments. To cover all essential technical areas in the field of digital and mobile, KVALITO works with reliable Technology Partners worldwide. For more information, please visit us at . Life Science Consultant - Computer System Validation

Location: Malaysia

The purpose of the role is to work with our clients to understand their needs, offer advice, solve problems, manage change, and improve efficiency.

Responsibilities:

CSV Compliance Oversight, review, and/or approval of Qualification/Validation Documents (e.g., Specifications, validation plans/reports, User Requirement Specifications, DQ, IQ, OQ, PQ, PV/CV, RTM, risk assessments, SOPs) in relation to the instrument, equipment, facilities, utilities, Automated systems, and manufacturing processes for the introduction of a new production site

Review and approval of 3rd party generated protocols and reports

Participate in equipment, process, and/or design FMEAs

Identify current and anticipated requirements for compliant facility & utility systems within the manufacturing environment

Ensure the archiving and filing of validation documentation associated with the project

Provide clear communication to all relevant stakeholders where quality-related challenges are envisaged and provide quality SME support to proactively drive solutions within a cross-functional, customer-orientated environment.

Ensure that current quality standards / regulatory requirements are interpreted appropriately and implemented in line with project remit

Participate in regulatory/internal audits as relevant

Involving other all quality-related activities (expectation, deviation, and CAPA)

Minimum Qualification and Experience

Education

Bachelor or Master degree in Life Sciences, Chemistry, Computer Science, Engineering or similar.

Language

Fluent in English

Work experience

At least 8 years\' professional experience in CSV preferably in the pharmaceutical or medical device industry.

Hard Skills

Strong expertise in GMP compliance

Strong expertise in process automation

Excellent expertise in CSV and GxP-related to Production & QA

Practical experience in and passion for information governance, IT quality, administration, and service management.

Equipment validation experience

Skilled in risk assessment methodologies, and project organizations

Strong organizational and project management skills, scheduling, and resource management

Familiar with compliance requirements (e.g., FDA, EMA GMP, GLP, GCP)

Soft Skills

Excellent people management, leadership, and decision-making skills.

Ability to facilitate a holistic perspective and understand business needs.

Motivated to continuously expand her/his knowledge of the life science industry.

Strong communication and problem-solving skills.

Ability to work globally to coordinate the work of associates at all levels.

Considerable organization awareness (e.g., the interrelationship of departments, business priorities) including experience in working cross-functionally and in global teams across cultures.

We offer great benefits

Flat hierarchies and responsibility from the beginning

People-oriented culture

Diversity and inclusion-focused environment

Global client projects in a multinational environment

Flexible working hours and home office

Involvement in global conferences

Individual professional development, training, and coaching

Unlimited full employment contract

Excellent remuneration package consisting of a competitive salary plus a substantial bonus

Contact

If you have the necessary background and experience and would like to join a small team responsible for a truly global operation, then please send your application to recruiting(at)kvalito.ch including your:

CV, cover letter, and supporting documents (i.e., diplomas, certificates, references)

Availability - earliest start date

Salary expectations

Location preference

We are looking forward to your application.
Your KVALITO Team.

Kvalito